Status:
UNKNOWN
Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
CML, Chronic Phase; TKI
Eligibility:
All Genders
18+ years
Brief Summary
The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new...
Eligibility Criteria
Inclusion
- Male or female patients ≥18 years of age;
- CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;
- Patients who must sign informed consent before screening
Exclusion
- T315I mutation ; Y253F/H, E255K/V, F359C/V/I mutations in the nilotinib group;
- Entry into another therapeutic clinical trial;
- Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
- History of neurological or psychiatric disorders, including epilepsy or dementia;
- Major surgery within 4 weeks prior to Day 1 of study;
- Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
- Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
- ECOG≥3;
- Patients who are unable to compliance with study or follow-up procedures;
Key Trial Info
Start Date :
September 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT04739826
Start Date
September 25 2020
End Date
December 1 2025
Last Update
November 3 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215000